Macrophage Stimulating Factor in the Treatment of Diabetic Wounds

Summary

With the aging of the population, the incidence of diseases such as diabetes, chronic atherosclerotic occlusion, cerebrovascular disease, and cancer is increasing year by year, and has led to an increasing incidence of chronic wounds such as diabetic foot, ischaemic ulcers, venous ulcers, pressure injuries, and radiation ulcers. In addition to the high age and chronic diseases that make the treatment of wounds difficult and long, chronic wounds remain in the proliferative stage, unable to carry out normal repair, which is also an important reason for the prolonged healing of wounds, which seriously affects the quality of life of patients and creates a huge social and family burden. In the United States, chronic hard-to-heal wounds exist in approximately 6.5 million people each year, costing the healthcare system more than $25 billion annually and increasing each year with the increased prevalence of diabetes and other diseases that affect wound healing. How to make chronic wounds heal quickly and well is a huge challenge that affects people\'s access to health today.

Macrophages are important cells involved in the inflammatory and proliferative phases of wounds, and are thought to play a key role in regulating the inflammatory response of wounds and promoting wound repair and reconstruction. Recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF), as a multifunctional haematopoietic factor, can stimulate the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophage and promote their peripheral transfer, as well as enhance phagocytosis and secretion of granulocytes and macrophages. Therefore rhGM-CSF is thought to have a possible positive role in the treatment of acute and chronic wounds and has been confirmed in several basic and clinical studies.

Topical human granulocyte macrophage stimulating factor gel (JinFuNing), which has been approved and marketed by the state for the treatment of acute and chronic wounds, is able to play a role in promoting wound repair, neovascularisation, and epithelial crawling, and has already achieved a certain degree of efficacy in promoting wound healing. This study accumulates clinical evidence-based medical evidence for more precise use of topical human granulocyte macrophage stimulating factor gel, and explores the clinical efficacy and safety of Jinfuning in the granulation growth phase of diabetic wounds.

Conditions

• Diabetic Wound

Interventions

DRUG

Topical Human Granulocyte Macrophage Stimulating Factor Gel

Human granulocyte macrophage colony-stimulating factor (rhGM-CSF), as a multifunctional haematopoietic factor, stimulates the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophages and promotes their peripheral translocation, as well as enhances phagocytosis and secretion of granulocytes and macrophages \[11\]. Since macrophages are key players in regulating the inflammatory response of wounds and promoting wound repair, rhGM-CSF is thought to potentially play a positive role in the treatment of acute and chronic wounds.

DRUG

Saline (NaCl 0,9 %) (placebo)

placebo

Sponsors & Collaborators

• Peking University Third Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-12

Primary Completion

2025-03-12

Completion

2025-10-01

Countries

• China

Study Locations